Acute sinusitis or exacerbation of subacute or chronic sinusitis. MedDRA version: 9.1 Level: LLT Classification code 10040753 Term: Sinusitis
Conditions
Interventions
Trade Name: AMOXIC.AC.CLAVUL.ABC
Pharmaceutical Form: Tablet
Sponsors
GALSOR S.R.L.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 8.Male, females 9.Age > 18 years. 10.Clinica diagnosis of acute sinusitis, or of exacerbation of subacute or chronic sinusitis, confirmed radiologically with a CTA scan image 11.Presence of mucus in the paranasal sinuses 12.Facial pain and congestion of the mucosa of paranasal sinuses since at least three days Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Clinical conditions (systemic pathologies, or other) that can interfere with the assessment of the safety and efficacy of the experimental product like for example: - viral or allergic rhinitis, with active secretive symptoms - presence of visible nasal polyps - diagnosis of immobile cilia syndromes - diseases causing immunodeficiencies - cystic fibrosis - immunocompromissione - renal block - dialysis - other pathologies of other apparatus that, in the opinion of the investigator, are interfering. Necessity of a supplemental antibiotic therapy, due to other pathologies, besides that for the treatment of sinusitis. Smoke during the period of the study History of intolerance or allergy to the components of SINUclean DM Medical or surgery intervention that can jeopardize the complete effectuation of the experimentation, in the four weeks preceding the signature of the informed consent.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of the study i sto demonstrate, in the studied cases, a percentage of remission of the sinusitis symptoms linked to the presence of mucus in the paranasal sinuses superior in the group treated with SINUclean DM, in comparison with the group treated with saline, or not treated with co-adjuvant treatment.;Secondary Objective: The secondary objective of the study is the time to remission of the symptoms of sinusitis, following the co-adjuvant treatment, specifically for those symptoms connected to the presence of mucus in the para-nasal sinuses: facial pain, nasal anterior and posterior dripping, nasal congestion, pain caused by manual pression in the zones interested by facial pain. Other objectives are the percentage and the time of the clinical healing of the acute episode of sinusitis, following association of the co-adjuvant treatment to the antibiotic therapy.;Primary end point(s): The primary endpoint of the study i sto demonstrate, in the studied cases, a percentage of remission of the sinusitis symptoms linked to the presence of mucus in the paranasal sinuses superior in the group treated with SINUclean DM, in comparison with the group treated with saline, or not treated with co-adjuvant treatment. | — |
Countries
Italy
Outcome results
None listed